8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
OLYMPUS REPLY GLUCOSE REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OMNIFIT HFX HIP STEM SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE
FDA 510(k)
FDA Unclassified
·Unknown
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
EXTENSION
FDA Adverse Event
Injury
·ST JUDE MEDICAL NEUROMODULATION·Product code LGW·June 23, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 28, 2013
LIFECARE PCA 3 V5.06
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code MEA·November 22, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024